ID
44564
Beschrijving
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Screening Part 5 - Pulmonary function: Methacholine and Asthma-allergen challenge.
Link
https://clinicaltrials.gov/ct2/show/NCT00318630
Trefwoorden
Versies (2)
- 10-04-18 10-04-18 - Sarah Riepenhausen
- 27-09-21 27-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
27 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630
Screening Part 5 - Pulmonary function: Methacholine and Asthma-allergen challenge
Beschrijving
Pulmonary function tests: Methacholine Challenge
Alias
- UMLS CUI-1
- C0748133
- UMLS CUI-2
- C0430567
Beschrijving
Methacholine Challenge Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0748133
- UMLS CUI [1,3]
- C0430567
Beschrijving
Inhaled Substance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205535
- UMLS CUI [1,2]
- C0600370
- UMLS CUI [2,1]
- C0205535
- UMLS CUI [2,2]
- C0036082
Beschrijving
Following the baseline assessment in which FEV1 is measured after inhalation of saline, subjects are to inhale doubling increments of Methacoline (provocholine) until a ≥20 percent fall in FEV1 from the baseline saline value is achieved. 0.000 is the concentration value for saline.
Datatype
text
Maateenheden
- mg/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0600370
Beschrijving
Use this item, if historical concentrations instead of the concentrations given in the item "challenge concentration (New Subjects)" are used. Following the baseline assessment in which FEV1 is measured after inhalation of saline, subjects are to inhale doubling increments of Methacholine (provocholine) until a ≥20percent fall in FEV1 from the baseline saline value is achieved. Use 0.000 for saline inhaltation.
Datatype
float
Maateenheden
- mg/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0600370
Beschrijving
Fill in only for saline inhalation and new subjects.
Datatype
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0001559
Beschrijving
Stop Time of Inhalation
Datatype
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0001559
Beschrijving
Both timepoints must be filled after each inhalation. Time relative to stop time of inhalation.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0205535
- UMLS CUI [1,3]
- C0748133
Beschrijving
Pulmonary function time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Beschrijving
FEV1 Result
Datatype
float
Maateenheden
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C0430567
Beschrijving
Pulmonary function tests: Post-Methacholine Challenge
Alias
- UMLS CUI-1
- C0231921
- UMLS CUI-2
- C0430567
- UMLS CUI-3
- C0439568
Beschrijving
Date of post-challenge FEV1
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Beschrijving
Time relative to end of challenge: Post-challenge 6 measurements are required.
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Beschrijving
Record use of rescue Salbutamol on the Concomitant Medications page.
Datatype
float
Maateenheden
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0439568
Beschrijving
PC20 (Methacholine Challenge)
Alias
- UMLS CUI-1
- C1446561
- UMLS CUI-2
- C0600370
- UMLS CUI-3
- C0429706
- UMLS CUI-4
- C0547047
Beschrijving
Date of challenge
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0430567
Beschrijving
Provocative concentration resulting in a 20% reduction in FEV1.
Datatype
float
Maateenheden
- mg/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0600370
- UMLS CUI [2,1]
- C0429706
- UMLS CUI [2,2]
- C0547047
Beschrijving
Skin Prick Test
Alias
- UMLS CUI-1
- C0430561
Beschrijving
Fill out once.
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0430561
Beschrijving
Time results read
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0430561
Beschrijving
Allergen used
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0002092
- UMLS CUI [1,2]
- C0430561
Beschrijving
Response
Datatype
text
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0430561
Beschrijving
Wheal
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1]
- C3827475
Beschrijving
allergen usage in challenge
Datatype
text
Alias
- UMLS CUI [1,1]
- C0002092
- UMLS CUI [1,2]
- C0457083
- UMLS CUI [1,3]
- C0006265
Beschrijving
Pulmonary function tests: pre-asthma-allergen challenge
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0006265
- UMLS CUI-3
- C0002092
- UMLS CUI-4
- C0439565
Beschrijving
pre-asthma-allergen pulmonary function test date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0024119
- UMLS CUI [1,3]
- C0006265
- UMLS CUI [1,4]
- C0002092
- UMLS CUI [1,5]
- C3812758
Beschrijving
Time relative to start of challenge. 3 pre-saline measurements are required.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0748133
Beschrijving
Time of FEV1
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Beschrijving
FEV1 Reading
Datatype
float
Maateenheden
- L
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0429706
Beschrijving
Pulmonary function tests: asthma-allergen Challenge
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0006265
- UMLS CUI-3
- C0002092
Beschrijving
asthma-allergen challenge date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0006265
- UMLS CUI [1,3]
- C0002092
Beschrijving
Inhaled Substance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205535
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [2,1]
- C0205535
- UMLS CUI [2,2]
- C0036082
Beschrijving
Baseline FEV1 measurements were first taken using saline. During the challenge at screening the final concentration of allergen was determined when a fall in FEV1 of >15percent from the baseline value was achieved. 0.000 is the concentration value for saline.
Datatype
text
Maateenheden
- SQU/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0002092
Beschrijving
Fill in only for saline inhalation.
Datatype
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0001559
Beschrijving
Stop Time of Inhalation
Datatype
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0001559
Beschrijving
Time relative to stop time of inhalation. Timepoints 2, 3 and 4 minutes postinhalation are only to be used for post-saline-inhalation (all three have to be done); 5 and 10 minutes post-inhalation are only for post-allergen-inhalation measurements (both have to be done for each allergen concentration).
Datatype
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0205535
- UMLS CUI [1,3]
- C0748133
Beschrijving
Pulmonary function time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Beschrijving
FEV1 Result
Datatype
float
Maateenheden
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C0006265
- UMLS CUI [1,3]
- C0002092
Beschrijving
Pulmonary function tests: Post-asthma-allergen Challenge
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0006265
- UMLS CUI-3
- C0002092
- UMLS CUI-4
- C0439568
Beschrijving
Date of post-challenge FEV1
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Beschrijving
Salbutamol should be administered after the 10hrs post-challenge measurement. Record use of rescue Salbutamol on the Concomitant Medications page.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Beschrijving
Time of post-challenge FEV1
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Beschrijving
Reading 1 of post-challenge FEV1
Datatype
float
Maateenheden
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0439568
Beschrijving
Not to be done for timepoints 15, 20, 30 and 45 mins.
Datatype
float
Maateenheden
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0439568
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Screening Part 5 - Pulmonary function: Methacholine and Asthma-allergen challenge
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